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Australasian Psychiatry • Vol 11, No 4 • December 2003 478 Clinical Practice Guidelines DEAR SIR, I am writing to you regarding the ‘Summary of guideline for the treat- ment of bipolar disorder’, published in your March 2003 issue, 1 which is in general an excellent paper. How- ever, it does not take into account the realities of everyday private practice. For example, the drug Lamotrigine is recommended on a number of occa- sions throughout the article: on p. 49 as a mood stabilizer in bipolar depres- sion, on p. 51 as a second choice for rapid cycling and first choice for non-rapid cycling. Even though this medication has significant published literature to support these recom- mendations, it is not currently avail- able in Australia for the indications outlined and under the Pharma- ceutical Benefits Scheme (PBS) it is approved for use only in ‘epileptic seizures not controlled by other anti- epileptic drugs’; its only use both on and off the PBS is in ‘partial and generalized seizures in adults and children’. I raise this point because, after reading the summary of treat- ment guidelines and having read the very similar American equivalent, I contacted the drug company that markets Lamotrigine (known as Lam- ictal in Australia), Glaxo, Smith Kline and I was told that this drug is cur- rently not indicated for use in mood disorders in Australia and, further- more, that the company is not currently marketing the drug to psy- chiatrists in Australia. I was told in no uncertain terms that until approval was granted by the Thera- peutic Goods Administration for those indications, I would be using the drug against the company’s wishes and at my own risk. Perhaps one of the problems with expert committees is that they do not have on them anyone in everyday private practice. I noticed that the Royal Australian and New Zealand College of Psychiatrists Clinical Practice Guideline Team for Bipolar

Clinical Practice Guidelines

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Page 1: Clinical Practice Guidelines

Aus

tral

asia

n Ps

ychi

atry

• V

ol 1

1, N

o 4

Dec

embe

r 20

03

478

Clinical Practice Guidelines

DEAR SIR,

I am writing to you regarding the‘Summary of guideline for the treat-ment of bipolar disorder’, publishedin your March 2003 issue,

1

which isin general an excellent paper. How-ever, it does not take into account therealities of everyday private practice.

For example, the drug Lamotrigine isrecommended on a number of occa-sions throughout the article: on p. 49as a mood stabilizer in bipolar depres-sion, on p. 51 as a second choice forrapid cycling and first choice fornon-rapid cycling. Even though thismedication has significant publishedliterature to support these recom-mendations, it is not currently avail-able in Australia for the indicationsoutlined and under the Pharma-ceutical Benefits Scheme (PBS) it isapproved for use only in ‘epilepticseizures not controlled by other anti-epileptic drugs’; its only use both onand off the PBS is in ‘partial andgeneralized seizures in adults andchildren’. I raise this point because,after reading the summary of treat-ment guidelines and having read thevery similar American equivalent,I contacted the drug company thatmarkets Lamotrigine (known as Lam-ictal in Australia), Glaxo, Smith Klineand I was told that this drug is cur-rently not indicated for use in mooddisorders in Australia and, further-more, that the company is notcurrently marketing the drug to psy-chiatrists in Australia. I was toldin no uncertain terms that untilapproval was granted by the Thera-peutic Goods Administration forthose indications, I would be usingthe drug against the company’swishes and at my own risk.

Perhaps one of the problems withexpert committees is that they do nothave on them anyone in everydayprivate practice. I noticed that theRoyal Australian and New ZealandCollege of Psychiatrists ClinicalPractice Guideline Team for Bipolar

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Australasian Psychiatry

• Vol 11, N

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Decem

ber 2003

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Disorder included a professor of psy-chiatry, a senior lecturer at the schoolof psychiatry, a research officer, anda research psychologist. In fact, morethan half of the College members arein private practice where recommen-dations like these are unable to beused; unfortunately, we are muchmore open to the dangers of litiga-tion than persons protected by largeinstitutions.

I hope this letter can be taken asconstructive criticism and perhaps, infuture, the non-approved status of adrug can be highlighted, even with acautionary note about off-label usage.

REFERENCE

1.

Mitchell PB, Malhi GS, Redwood BL, Ball J for theRANZCP Clinical Practice Guideline Team for BipolarDisorder. Summary of guideline for the treatment ofbipolar disorder.

Australasian Psychiatry

2003;

11

:39–53.

Kevin McNamara

Currumbin Qld